Prostate CancerPhase 1/2NCT00503984

A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

A Phase 1/2 study testing Azacitidine, Docetaxel and Prednisone in people with Prostate Cancer and Pain, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes. Read more about this study

Who is it for?: Ages 18 to 120 years, men only
Conditions the study is for: Prostate Cancer, Pain
What is being tested?: Azacitidine, Docetaxel and Prednisone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: May 2007to Jun 2015
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient who had histologically confirmed adenocarcinoma of the prostate.
Patient must have radiologically documented metastatic disease.
Patients should have received at least 12 weeks of docetaxel chemotherapy or a cumulative docetaxel dose of 300 mg/m2 and have disease progression on docetaxel-based therapy. Patients must have progressed after prior hormonal therapy (e.g. medical or surgical castration) as defined by a castrate level of testosterone (less than 50 ng/mL). If patient underwent medical castration, it must be continued during the study.
Progressive disease may be documented by:
Non-measurable disease:
Serum PSA progression defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apart and an absolute value greater than 2.0 ng/ml or,

Show all 27Show fewer

Appearance of two or more new lesions on bone scan.
Patients with treated epidural lesions and no other epidural progression will be eligible.
Measurable disease
Documented progression of disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria demonstrating at least one visceral or soft tissue metastatic lesion (including new lesion).
Nodal or visceral progression will be sufficient for trial entry independent of PSA
Only lymph nodes ≥ 2 cm in diameter will be used to assess for a change in size.
Previously irradiated lesions, primary prostatic lesion, and bone lesions will be considered non-measurable disease.
Patient is 18 years or older.
Patient had a Karnofsky Performance Status (KPS) of at least 70% or Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
Life expectancy of > 6 months.
Patient with adequate organ function as defined as
Absolute Neutrophils Count greater than 1500 cells/mm3
Platelets greater than 100,000 cells/mm3
Hemoglobin greater than 8 g/dL,
Adequate liver function as documented by:
Total Bilirubin </= 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
AST and ALT </= 2.5 ULN. (In determining eligibility the more abnormal of the two values (AST or ALT) should be used.)
Serum creatinine </= 2.0 mg/dl or </= 1.5 x institutional upper limit of normal.
Male patient must be willing to use an acceptable barrier method for contraception; and must agree not to father a child whilst receiving treatment with Azacitidine and up to six months after last dose.
Patients may have a history of prior malignancy (≥ 5 years prior) provided that the patient is currently disease free and off all therapy for that malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Patients must be informed of the investigational nature of the treatment and must give signed written and informed consent.

Who cannot join

Patients who have received strontium 89 (metastron®), Samarium 153 (quadramet®) radiation therapy within 8 weeks of enrollment.
Evidence of significant active infection during screening for eligibility.
Patients who have had a psychiatric illness that could potentially interfere with completion of treatment according to protocol.
Patients who had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no wash-out period for patients who received Zytiga.
Patient who had brain metastases.
Patient who had history of allergic reactions attributed to compound or similar chemical or biological composition to azacitidine (Vidaza®) or docetaxel or other drugs formulated with polysorbate 80 or mannitol.
Patient had major surgical procedure within 28 days before Day 1 of treatment.
Hepatic malignancy.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase I/II Study of Azacitidine (Vidaza), Docetaxel and Prednisone for Patients With Hormone Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere Containing Regimen.

Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.

Read the detailed description

Study design A phase I/II clinical trial in patients with hormone refractory metastatic prostate cancer.

Primary objective phase I component of study:

To determine a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.

Primary objective phase II component of study:

To determine the therapeutic efficacy of combined therapy of azacitidine, docetaxel, and prednisone, in the treatment of hormone refractory metastatic prostate cancer. The primary measure of therapeutic efficacy is response, defined as prostate-specific antigen (PSA) response, complete response (CR), or partial response (PR).

Secondary endpoints are toxicity, duration of response, progression-free survival, and overall survival.

Conditions: Prostate Cancer, Pain
Being tested: Azacitidine, Docetaxel, Prednisone, GADD45α methylation and expression analysis, Pegfilgrastim
Keywords: Adenocarcinoma of the prostate, Recurrent prostate cancer, Stage IV prostate cancer, Pain
Medical subject headings: Prostatic Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzacitidineDrug
Also called Vidaza®
Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.
DocetaxelDrug
Also called Taxotere®
Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.
PrednisoneDrug
Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.
GADD45α methylation and expression analysisGenetic
Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing.
Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so.
PegfilgrastimDrug
Also called Neulasta
Growth factor support.Granulocyte-colony stimulating factor (G-CSF)
FilgrastimDrug
Also called Neupogen
Growth factor support. Granulocyte-colony stimulating factor (G-CSF)

Study groups in NCT00503984
Study group	Role	What they receive
Phase 1 - Aza + Doc	Experimental	Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim). Receives: Drug: Azacitidine; Drug: Docetaxel; Drug: Prednisone; Genetic: GADD45α methylation and expression analysis; Drug: Pegfilgrastim; Drug: Filgrastim
Phase 2 - Aza + Doc RPTD	Experimental	Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim). Receives: Drug: Azacitidine; Drug: Docetaxel; Drug: Prednisone; Drug: Pegfilgrastim; Drug: Filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.
Measured: Up to 1.5 years
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)
Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.
Measured: Up to 1.5 years
Number of Participants Achieving Prostate-specific Antigen (PSA) Response.
Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
Measured: Up to 4.5 years.
Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.
Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: "Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; "
Measured: Up to 4.5 years

Secondary outcomes (4)

Duration of Response
Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
Measured: Up to 4.5 years.
Progression-Free Survival (PFS)
The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier.
Measured: Up to 4.5 years
Overall Survival (OS)
The time from the date of initiation of study treatment until date of death from any cause.
Measured: Up to 4.5 years.
Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.
Measured: Up to 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Jun 2015

First posted19 Jul 2007 (estimated)
Study startMay 2007
Primary completionJun 2015
Study completionJun 2015

Why it stopped: Withdrawal of Funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00503984
Sponsor's protocol ID: 20061143
Other IDs: SCCC-2006080, WIRB-20070344, 20140376
Status last verified: May 2016
First submitted: 17 Jul 2007
Last updated: 9 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Singal R, Ramachandran K, Gordian E, Quintero C, Zhao W, Reis IM. Phase I/II study of azacitidine, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy. Clin Genitourin Cancer. 2015 Feb;13(1):22-31. doi: 10.1016/j.clgc.2014.07.008. Epub 2014 Aug 1.
PubMed 25178642

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Azacitidine (Vidaza), Docetaxel and Prednisone for Patients With Hormone Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere Containing Regimen.
ClinicalTrials.gov ID: NCT00503984
Acronym / sponsor ID: 20061143
Conditions: Prostate Cancer, Pain
Keywords: Adenocarcinoma of the prostate, Recurrent prostate cancer, Stage IV prostate cancer, Pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Withdrawal of Funding
Enrolment: 22 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: May 2007
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 19 Jul 2007 (estimated)
Results: Posted 20 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.

Detailed description

Study design A phase I/II clinical trial in patients with hormone refractory metastatic prostate cancer.

Primary objective phase I component of study:

Primary objective phase II component of study:

Secondary endpoints are toxicity, duration of response, progression-free survival, and overall survival.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase 1 - Aza + Doc	Experimental	Drug: Azacitidine, Drug: Docetaxel, Drug: Prednisone, Genetic: GADD45α methylation and expression analysis, Drug: Pegfilgrastim, Drug: FilgrastimPhase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
Phase 2 - Aza + Doc RPTD	Experimental	Drug: Azacitidine, Drug: Docetaxel, Drug: Prednisone, Drug: Pegfilgrastim, Drug: FilgrastimRecommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).

Who may qualify

Ages: 18 to 120 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Patient who had histologically confirmed adenocarcinoma of the prostate.
Patient must have radiologically documented metastatic disease.
Patients should have received at least 12 weeks of docetaxel chemotherapy or a cumulative docetaxel dose of 300 mg/m2 and have disease progression on docetaxel-based therapy. Patients must have progressed after prior hormonal therapy (e.g. medical or surgical castration) as defined by a castrate level of testosterone (less than 50 ng/mL). If patient underwent medical castration, it must be continued during the study.
Progressive disease may be documented by:
Patient is 18 years or older.

Key exclusion criteria (8 listed)

Patients who have received strontium 89 (metastron®), Samarium 153 (quadramet®) radiation therapy within 8 weeks of enrollment.
Evidence of significant active infection during screening for eligibility.
Patients who have had a psychiatric illness that could potentially interfere with completion of treatment according to protocol.
Patients who had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no wash-out period for patients who received Zytiga.
Patient who had brain metastases.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzacitidineAlso: Vidaza®Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.	Drug	Phase 1 - Aza + Doc, Phase 2 - Aza + Doc RPTD
DocetaxelAlso: Taxotere®Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.	Drug	Phase 1 - Aza + Doc, Phase 2 - Aza + Doc RPTD
PrednisonePatient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.	Drug	Phase 1 - Aza + Doc, Phase 2 - Aza + Doc RPTD
GADD45α methylation and expression analysisPeripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing. Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so.	Genetic	Phase 1 - Aza + Doc
PegfilgrastimAlso: NeulastaGrowth factor support.Granulocyte-colony stimulating factor (G-CSF)	Drug	Phase 1 - Aza + Doc, Phase 2 - Aza + Doc RPTD
FilgrastimAlso: NeupogenGrowth factor support. Granulocyte-colony stimulating factor (G-CSF)	Drug	Phase 1 - Aza + Doc, Phase 2 - Aza + Doc RPTD

Primary outcome

Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
Time frame: Up to 1.5 years
Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)
Time frame: Up to 1.5 years
Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.
Number of Participants Achieving Prostate-specific Antigen (PSA) Response.
Time frame: Up to 4.5 years.
Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.
Time frame: Up to 4.5 years
Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: "Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; "

4 secondary outcomes

Duration of Response
Time frame: Up to 4.5 years.
Progression-Free Survival (PFS)
Time frame: Up to 4.5 years
Overall Survival (OS)
Time frame: Up to 4.5 years.
Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.
Time frame: Up to 4.5 years

Results and safety

Results posted to the registry on 20 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Level 1 - 75 Aza + 60 Doc	3	3
Phase 1: Level 2 - 75 Aza + 75 Doc	3	1
Phase 1: Level 3 - 100 Aza + 75 Doc	3	3
Phase 1: Level 4 - 150 Aza + 75 Doc	6	6
Phase 2 - Aza + Doc Initial RPTD	6	5
Phase 2 - Aza + Doc Reduced RPTD	1	1

Primary outcome: Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)

Time frame: Up to 1.5 years. Number. Unit: mg/m2

Measure	Phase 1 - Aza + Doc n = 15
Initial RPTD Azacitidine (mg/m2)	150
Initial RPTD Docetaxel (mg/m2)	75
Reduced RPTD Azacitidine (mg/m2)	75
Reduced RPTD Docetaxel (mg/m2)	75

Population analysed: Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.

Primary outcome: Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)

Time frame: Up to 1.5 years. Number. Unit: mg

Measure	Phase 1 - Aza + Doc n = 15
Initial RPTD Prednisone (mg)	5
Reduced RPTD Prednisone (mg)	5

Primary outcome: Number of Participants Achieving Prostate-specific Antigen (PSA) Response.

Time frame: Up to 4.5 years.. Number. Unit: participants

Measure	Phase 1: Level 1 - 75 Aza + 60 Doc n = 3	Phase 1: Level 2 - 75 Aza + 75 Doc n = 1	Phase 1: Level 3 - 100 Aza + 75 Doc n = 3	Phase 1: Level 4 - 150 Aza + 75 Doc n = 6	Phase 2 - Aza + Doc Initial RPTD n = 5	Phase 2 - Aza + Doc Reduced RPTD n = 1
Value	0	1	2	4	3	0

Population analysed: Of the 22 participants enrolled, only 19 were evaluable because they completed 2 or more cycles of protocol therapy.

Primary outcome: Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.

Time frame: Up to 4.5 years. Number. Unit: participants

Measure	Phase 1: Level 1 - 75 Aza + 60 Doc n = 2	Phase 1: Level 2 - 75 Aza + 75 Doc n = 0	Phase 1: Level 3 - 100 Aza + 75 Doc n = 2	Phase 1: Level 4 - 150 Aza + 75 Doc n = 3	Phase 2 - Aza + Doc Initial RPTD n = 3
Complete Response (CR)	0	–	1	0	0
Partial Response (PR)	0	–	0	1	1

Population analysed: Number of evaluable participants with measurable disease on CT scan. Only 10 of the 19 evaluable participants had measurable disease on CT Scan.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Level 1 - 75 Aza + 60 Doc	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Level 2 - 75 Aza + 75 Doc	0 of 4 (0%)	4 of 4 (100%)	Not reported
Level 3 - 100 Aza + 75 Doc	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Level 4 - 150 Aza + 75 Doc	4 of 12 (33.3%)	12 of 12 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25178642Singal R, Ramachandran K, Gordian E, Quintero C, Zhao W, Reis IM. Phase I/II study of azacitidine, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy. Clin Genitourin Cancer. 2015 Feb;13(1):22-31. doi: 10.1016/j.clgc.2014.07.008. Epub 2014 Aug 1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rakesh Singal, MD principal investigator

University of Miami Sylvester Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Azacitidine, Docetaxel and Prednisone in people with Prostate Cancer and Pain, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel) (time frame: Up to 1.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00503984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.